This content is current only at the time of printing. This document was printed on 23 June 2021. A current copy is located at http://www.plural-consulting.com/node/10851
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Prioritisation of chemicals nominated for review
The APVMA prioritises agricultural and veterinary chemicals nominated for review according to the scientific evidence supporting the nomination. This is based on advice received from the APVMA’s own scientific experts. Chemicals prioritised for review may be listed in the priority candidate review list, or other immediate regulatory action may be taken.
In accordance with the legislative criteria, the APVMA evaluates chemicals nominated for review based on key criteria of concern including the scientific evidence on potential risks to human health (toxicology and occupational health and safety), environment, residues and trade, and target crop and animal safety and efficacy.
A formal reconsideration is not the only mechanism the APVMA uses to address concerns with registered products. When a problem is identified, we act quickly based on the scientific data and take appropriate action.
The APVMA continues to take regulatory action to manage risks to human health and safety, animals and the environment.
Chemicals that are nominated for review are assessed against the following criteria:
- reports of adverse experiences when registered products are used according to label instructions (for example, lack of efficacy or spray drift)
- research or evidence (eg, information from holders submitted under s161) that could impact approved use patterns
- our analysis of the science supporting international regulatory decisions.
Human health (toxicology and occupational health and safety)
Chemicals that are nominated for review are assessed for their effect on human health against the following criteria:
- demonstrated or potential adverse effects in humans
- acute and chronic risk
- scheduling of the chemical
- exposure to the chemical from food, including dietary exposure
- regulatory action taken overseas
- non-hazardous substances
- hazardous substances
- industrial exposure in Australia
- form of concentrated chemical (includes formulated products)
- exposure to working strength chemical (mixing, loading or application)
- frequency of application
- post-application exposure (handling of treated crops and animals)
- user exposure.
Chemicals that are nominated for review are assessed for their effect on the environment against the following criteria:
- environmental exposure
- form and method of application
- volume of use (kilograms per annum)
- scale of use (hectares per annum)
- persistence (soil or aquatic half-life)
- bioaccumulation potential
- mobility or leaching potential
- environmental toxicity
- aquatic toxicity
- terrestrial bird or mammalian toxicity
- terrestrial plant toxicity
- other non-target organisms
- sensitivity of receiving environment.
Residues and trade
Chemicals that are nominated for review are assessed for their impact on residues and trade against the following criteria:
- absence of maximum residue limits
- reported incidents of residue violations
- reported incidents of adverse effects on trade
- compatibility with other countries' maximum residue limits
- residues resulting from use according to the label and the appropriateness of existing directions (for example, hydroponic versus field use).
Note: Dietary exposure is considered under human health.
Chemicals that are nominated for review are assessed for their efficacy against the following criterion:
- lack of efficacy (confirmed report(s) of serious incident(s) of chemical failure; substantial incidents of chemical failure).
Target animal and crop safety
Chemicals that are nominated for review are assessed for their effect on target animal and crop safety against the following criteria:
- reported incidents of phytotoxicity and adverse interactions with target crops
- reported incidents of adverse effects to treated target animals.